BioLineRx phase 1/2a study of anti-tumour vaccine AGI-134 in metastatic solid tumours meets primary endpoint

BioLineRx Ltd., a pre-commercial-stage biopharmaceutical company focused on oncology, announced results from the phase 1/2a study of intratumoural cancer vaccine candidate, AGI-134, designed to evaluate the safety and biological activity of AGI-134 in patients with unresectable metastatic solid tumours. The study met its primary endpoint of AGI-134's safety and tolerability. In this first-in-human trial, a total of 38 patients were treated with AGI-134: 5 patients in part 1, the accelerated dose-escalation part of the study; and 33 patients in part 2, the dose expansion part of the study. Part 1 demonstrated that AGI-134 was safe and well tolerated, with no dose-limiting toxicities reported. The maximum tolerated dose was not reached and the recommended dose for part 2 of the study (RP2D) was determined to be up to 200mg. In the dose expansion part 2 of the study, AGI-134 was generally well-tolerated, with treatment-related adverse events being transient and mostly mild to moderate. Generation of an immune response and markers of clinical efficacy were assessed as secondary endpoints. Most patients analyzed showed an increase in Alpha-Gal antibodies, indicating increased overall immune activity. Additionally, increases in antigen presenting cells (APCs) were observed in most tissue samples analyzed, and T cell and macrophage tumour infiltration was seen in approximately one-third of evaluable patients' injected tumours, and in approximately half of evaluable patients' un-injected lesions. Radiological assessments found that 29 per cent of patients in the trial achieved best overall response of stable disease. Seven of the 11 patients who achieved stable disease had previously failed checkpoint-inhibitor therapy. "In this first-in-human, single-agent trial, we were encouraged with AGI-134's safety profile and the observed initiation of immune activity in patients," said Philip Serlin, chief executive officer of BioLineRx. "We plan to seek publication of our data at a medical congress in 2023, and in consultation with our scientific advisory board, we will determine the next steps for the programme in the first half of next year. We want to thank the patients who participated in this important trial, their caregivers, and our physician collaborators." The phase 1/2a clinical trial was a multicenter, open-label study, which recruited a total of 38 patients in the UK, Spain and Israel. The study had two parts: part one was an accelerated dose-escalation study in five patients to determine the maximum tolerated dose and the recommended dose for part 2 of the study; part two was a dose expansion study at the recommended dose in 33 patients, designed to evaluate the safety and tolerability of AGI-134, and to validate AGI-134's mechanism of action using a wide array of biomarkers. AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumours that is highly differentiated from other cancer immunotherapies. AGI-134 is designed to label cancer cells with alpha-Gal via intra-tumoural administration, thereby targeting the body's pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumours. Binding of anti-Gal antibodies to the treated tumours results in activation of the complement cascade, which destroys the tumour cells and creates a pro-inflammatory tumour microenvironment that also induces a systemic, specific anti-tumour (vaccine) response to the patient's own tumour neo-antigens. AGI-134 has been evaluated in numerous pre-clinical studies. In a mouse melanoma model, treatment with AGI-134 led to regression of established primary tumours and suppression of secondary tumour (metastases) development. Synergy has also been demonstrated in additional pre-clinical studies when combined with an anti-PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd. BioLineRx Ltd. is a pre-commercial-stage biopharmaceutical company focused on oncology. The company's lead development program, motixafortide, a novel selective inhibitor of the CXCR4 chemokine receptor, may support diverse therapeutic approaches in oncology and other diseases

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